Z-1126-03

Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage...

Name: Z-1126-03 Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage...
Creator: Olympus America Inc.
Published: 2003-03-05
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2003-03-05 / Terminated / root cause: software

FDA source

Olympus America Inc. began a recall of Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt on 2003-03-05. The reason FDA records is "Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1126-03
Status: Terminated
Initiated: 2003-03-05
Posted: 2003-08-12
Terminated: 2005-03-22
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
Root cause tag: software
FDA root cause: Other
Action: Olympus America, Inc. sent "Urgent-Device Correction" letters, dated 3/5/03, to the medical facilities, advising them of the software malfunction. The letter provides instructions to health care practitioners and that a new software release is being developed to prevent a recurrence.
Quantity in commerce: 856
Distribution: Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.
Product codes and lots: Versions 6.0 through 6.4

Product code LMB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)